- Delivery Method:
- VIA UPS and Electronic Mail
Recipient NameZhengliang Guo
- Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc.
17115 Gale Avenue
City of Industry, CA 91745
- Issuing Office:
- Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Mr. Guo:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (“you” or “the Firm”), imports and distributes electronic nicotine delivery system (ENDS) products for commercial distribution in the United States, and that the ENDS products are imported and offered for sale or distribution to customers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), the Firm’s ENDS products and its ENDS components and parts are tobacco products because they are intended or reasonably expected to be used with or for the human consumption of a tobacco product. E-liquids, ENDS products, and ENDS components and parts are tobacco products subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1.
Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the Act. These products include, but are not limited to, electronic nicotine delivery systems (including e-cigarettes), e-liquids, cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.
The FD&C Act requires “new tobacco products” to have premarket authorization. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3).
New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded
FDA has determined that you import, sell, and/or distribute to customers in the United States the following ENDS products without a marketing authorization order:
- Uwell Amulet Watch Pod System,
- Uwell Caliburn Pod Kit,
- Uwell Caliburn KOKO Kit, and
- Uwell Yearn Pod System
The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act. In addition, they are misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act. The introduction into interstate commerce of any tobacco product that is adulterated or misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). Additionally, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).
FDA finds your product particularly concerning because the design of Uwell Amulet Watch Pod System is likely to appeal to children because it is designed to conceal a tobacco product from parents, teachers, or other adults (See Exhibit A). Specifically, the product design for Uwell Amulet Watch Pod System contains features that resemble smartwatches (See Exhibit B) that are commonly worn by children and, therefore, your product can be carried and worn without revealing to parents, teachers, or other adults that the product is a tobacco product. FDA is concerned about the rising youth appeal and dramatic rise in youth use of ENDS products. Any efforts to entice minors to use tobacco products are of concern to FDA. Sales of such products to minors are prohibited, and FDA is concerned that your actions likely encourage unlawful sales, maintain or increase youth use, and contribute to the public health and safety concerns associated with ENDS products.
Conclusion and Requested Actions
It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the type described above may result in FDA’s initiating action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that any adulterated and/or misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct any violations that are referenced above, as well as violations that are the same as or similar to the ones stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Please note your reference number, ER2000038, in your response and direct your response to the following address:
DEM-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact Lillian Ortega at (240) 402-9041 or Lillian.Ortega@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products